FDA 510(k) Application Details - K012715

Device Classification Name	Oximeter, Reprocessed   More FDA Info for this Device
510(K) Number	K012715
Device Name	Oximeter, Reprocessed
Applicant	HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 BIRMINGHAM, AL 35211 US Other 510(k) Applications for this Company
Contact	TRACY COMAS Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	NLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2001
Decision Date	08/01/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review